Direction about advertisements: Peter Daryl Evans and Peter Evans Chef Pty Ltd

Material finding of fact and reasons for direction

1. Background
   1. Following a number of complaints received by the TGA in relation to the advertising of the BioCharger device on social media, the TGA undertook an investigation and issued two Infringement Notices to Peter Evans Chef Pty Ltd (Company) on 23 April 2020 for alleged breaches of the Therapeutic Goods Act 1989 (Cth) (TG Act). The alleged breaches referred to in the Infringement Notices were:
      1. advertising, on the website at [REDACTED] (Website), a therapeutic good, being the BioCharger, that was not entered in the Australian Register of Therapeutic Goods (Register) and not otherwise subject to an exemption, authority or approval under the TG Act; and
      2. advertising the BioCharger by a video posted on an associated Facebook page, in circumstances where the advertisement contained an unapproved restricted representation, being a reference to an effect against "Wuhan Coronavirus".
   2. When the Infringement Notices were given to the Company, you and the Company were also warned about the advertising of other goods being advertised on the Website which appeared to be therapeutic goods. In particular, the letter noted that advertisements of certain devices used in Red Light Therapy, Hyperbaric Oxygen Therapy and Cryotherapy on the Website appeared to contravene the TG Act.
   3. The letter further noted that the Website promoted a number of encapsulated vitamin products that bear some similarity to kinds of medicines listed on the Australian Register of Therapeutic Goods. You were advised that those goods may also be subject to the TG Act.
   4. Despite the previous warning given by the TGA when the infringement notices were issued, you and the Company continued to unlawfully advertise therapeutic goods on the Website.
   5. This unlawful advertising included advertisements for the 'BioCharger', a device that (as previously advised by the TGA) is a therapeutic good that is not entered in the Register. It further included the advertising of additional goods that were not entered in the Register, and the making of claims (on the Website and other websites linked to by the Website (Linked Websites)), that are prohibited or restricted representations or which contravene the Therapeutic Goods Advertising Code (No. 2) 2018 (Cth) (Advertising Code).
   6. Such advertising is a serious criminal offence under sections 42DL and 42DM of the TG Act, carrying penalties of up to 5 years' imprisonment and fines of up to $888,000 for an individual or $4.44 million for a body corporate. It may also give rise to civil penalties of up to $1.11 million for an individual or $11.1 million for a body corporate under subsections 42DLB and 42DMA of the TG Act. The same penalties apply for contravening a direction given by the TGA (see section 42DX of the TG Act).
   7. On 4 May 2021, the TGA sent you correspondence outlining our proposal to direct the Company, as well as you in your personal capacity, to cease advertising a number of therapeutic goods, and to cease making certain claims and representations in your advertising. You were advised to provide a response by 5pm on 14 May 2021.
   8. You were further advised that if your advertising came into full compliance by that date, the delegate would take that into account in making their decision, however the TGA reserved its rights to issue a direction as a guarantee of your ongoing compliance even if the unlawful advertising was removed.
   9. On 14 May 2021, your legal representatives, Mills Oakley, made submissions to the TGA on your behalf. Those submissions stated that the references to therapeutic goods not entered in the Register, and claims and representations contravening the TG Act and the Advertising Code, referred to in our proposal to direct were immediately removed [REDACTED]. I note that this indicates that you and the Company accept that the advertising was contrary to the TG Act, and do not contest the matters set out in the letter of 4 May 2021.
   10. The submissions go on to state that Mills Oakley continues to work with you and the Company to identify and remove further potentially unlawful content.
   11. For the reasons outlined below, I am of the view that the goods listed in Schedule 1 are therapeutic goods regulated by the TG Act, and that advertisements of those therapeutic goods for which you and the Company are responsible contravened the TG Act.
   12. I am further satisfied that it is appropriate to make a direction as a deterrent to any further non-compliance, and as a clear statement of the TGA's concerns about unlawful advertising of this kind, notwithstanding the above submissions and the removal of the relevant advertisements from the Website.
2. Power to make direction
   13. Subsection 42DV(1) of the TG Act provides that if, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of the TG Act, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods to do certain acts. Those acts include ceasing the advertisement or ceasing making a particular claim or representation made by the advertisement.
   14. A person will contravene subsection 42DLB(1) of the TG Act if that person advertises, or causes the advertising of, therapeutic goods, and one of a series of subsections applies to the advertisement. Those include, relevantly:
       1. subsection 42DLB(2) of the TG Act, which applies to an advertisement if it contains a prohibited representation and no permission under section 42DK of the TG Act is in force in relation to that representation;
       2. subsection 42DLB(4) of the TG Act, which applies to an advertisement if it contains a restricted representation (whether in express terms or by necessary implication), and neither an approval under section 42DF nor a permission under section 42DK of the TG Act is in force in relation to that representation; and
       3. subsection 42DLB(9) of the TG Act (read with regulation 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (Regulations)), which applies to an advertisement if it refers to therapeutic goods that are not entered in the Register and which are not the subject of an exemption, approval or authority under the TG Act or regulations made under the TG Act, other than a reference authorised or required by a government or government authority.
   15. A person will contravene subsection 42DMA(1) of the TG Act if that person advertises, or causes the advertising of, therapeutic goods, and the advertisement does not comply with the Advertising Code. The Advertising Code provides, relevantly, that an advertisement for therapeutic goods:
       1. must support the safe and proper use of therapeutic goods by not exaggerating product efficacy or performance (paragraph 10(a)(ii) of the Advertising Code); and
       2. must not contain an endorsement from, or imply that the therapeutic goods are endorsed by, a health professional (paragraph 16(2)(c) of the Advertising Code).
3. The Advertisements
   16. The Website advertised a number of therapeutic goods, as listed in Schedule 1 (the Goods). Each advertisement included a description of the Goods in question, along with a link labelled 'Learn More' that hyperlinked to a Linked Website at which the Goods can be purchased. The Uniform Resource Locator (URL) for each of the relevant pages on the Website are included in the table in Schedule 1.
   17. I am satisfied that each of the Goods is a therapeutic good within the meaning of the TG Act. Therapeutic goods, as defined at subsection 3(1) of the TG Act, are goods 'that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for therapeutic use...', subject to a series of exceptions in paragraphs (c) to (h) of the definition.
   18. Therapeutic use relevantly includes use in or in connection with 'preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons' or 'influencing, inhibiting or modifying a physiological process in persons'. Each of the Goods are promoted, on the Primary Website and the Linked Websites, as being for therapeutic uses (examples of which are included in Schedule 1). Noting the therapeutic uses referred to in Schedule 1, and that none of the exceptions at paragraphs (c) to (h) apply, I find that each of the Goods is a therapeutic good.
   19. Each of the goods was advertised on a page on the Website. The Company owns and operates the Website, and you are the sole director/secretary and controlling mind of the Company. Each of the advertisements of the Goods on the Website appears to be intended to promote the use or supply of the relevant goods, including by linking to Linked Websites at which those goods are available for purchase.
   20. I therefore conclude that you and the Company advertised, or caused the advertising of, the Goods on the Website, as well as on the Linked Websites in circumstances where you directed persons viewing the Website to those websites.
4. References to goods that are not entered in the ARTG
   21. The Goods, with the exception of the 'Q Magnet' range (ARTG 132324), are not entered in the Register and are not subject to any relevant exemption, approval or authority. The references to those goods in advertisements on the Website were not authorised or required by a government or government authority.
   22. In those circumstances, I am satisfied that subsection 42DLB(9) of the TG Act applies to the advertisements of the Goods (other than ARTG 132324) on the Website, and that you and the Company have thereby contravened subsection 42DLB(1) of the TG Act.
5. Representations and claims otherwise contravening the TG Act
   23. The Linked Websites further included a number of restricted and prohibited representations (within the meaning of sections 28 and 30 of the Advertising Code, respectively). Those restricted and prohibited representations are listed in Schedule 2.
   24. Neither a permission under section 42DK of the TG Act, nor an approval under section 42DF of the TG Act, was in force in relation to the restricted representations listed at Schedule 2, and I am satisfied that subsection 42DLB(4) of the TG Act therefore applies to the advertisements in question. I am further satisfied that you and the Company, having caused the advertising of therapeutic goods on the Linked Website, have contravened subsection 42DLB(1) of the TG Act in relation to the advertisements containing restricted representations referred to in Schedule 2.
   25. No permission under section 42DK of the TG Act was in force in relation to the prohibited representation referred to at Schedule 2, and I am satisfied that subsection 42DLB(2) of the TG Act applied to the advertisement in question. I am further satisfied that you and the Company, having caused the advertising of the therapeutic goods on the Linked Website, have contravened subsection 42DLB(1) of the TG Act in relation to the advertisement containing a prohibited representation referred to at Schedule 2.
   26. Advertisements on the Website further included a number of claims that do not comply with the Advertising Code, including claims stating or implying that the therapeutic goods were endorsed by a health professional, or which exaggerated product efficacy and performance. Those claims are listed in Schedule 3. I am satisfied that the advertisements in which those claims were made did not comply with the Advertising Code, and that you and the Company thereby contravened subsection 42DMA(1) of the TG Act.
6. Conclusion
   27. For the reasons set out above, I am satisfied that there have been contraventions of subsections 42DLB(1) and 42DMA(1) of the TG Act in relation to the advertising of therapeutic goods on the Website and Linked Websites. I am further satisfied that you and the Company are responsible for the relevant advertising on the Website and Linked Websites.
   28. It is therefore open to me to direct you and the Company to cease the relevant advertisements, and cease making the prohibited and restricted representations and claims in contravention of the Advertising Code referred to above.
   29. In deciding whether to issue the direction, I have taken into account submissions made by your solicitors, Mills Oakley, in response to the proposal to direct of 4 May 2021. In doing so, I have noted that you and the Company sought advice after receiving the proposal to direct, and subsequently removed the advertising referred to in the proposal prior to being directed to do so.
   30. I have given those submissions some weight. I note, however, that this latest non-compliance comes only one year after the Company was given two infringement notices for contraventions of subsection 42DLB(1). Those infringement notices related to one of the therapeutic goods that are the subject of this matter, being the BioCharger.
   31. In correspondence accompanying those infringement notices, I made it clear that the BioCharger is a therapeutic good within the meaning of the TG Act. That correspondence also specifically raised the TGA's concerns regarding the advertising of hyperbaric oxygen chambers, red light therapy devices and complementary medicines that were not entered in the Register, and warned you and the Company that the advertising of several of those goods appeared to be unlawful.
   32. Notwithstanding that warning, you have continued to advertise the BioCharger (which is still not entered in the Register), along with a range of other therapeutic goods including the HBOT Device, a red light therapy device and complementary medicines. This resumption of unlawful advertising shows, at best, a lack of insight and diligence in complying with your obligations, and those of the Company, under the TG Act. At worst, it could be construed as a wilful failure to comply with the law.
   33. While the advertisements on the Website have now been taken down, the steps referred to in your submissions do not provide sufficient confidence that you and the Company will not engage in further unlawful advertising in the future. I have therefore decided that it is necessary to proceed to a formal direction under section 42DV of the TG Act, in order to:
       1. make it abundantly clear that you and the Company are not permitted to advertise the therapeutic goods listed at paragraph 1 of the direction, nor make the claims and representations at paragraphs 2 and 3;
       2. express, both to yourself and to the public at large, the TGA's concern about unlawful advertising of the kind in issue here; and
       3. provide some further assurance as to the ongoing compliance of yourself and the Company.

Effect of not complying with this/these directions

Contravening a direction or a condition of a direction made under subsections 42DV(1) or (2) of the TG Act, is a criminal offence under section 42DW of the TG Act, and may give rise to civil penalties under section 42DX, which could lead to court action against you.

The TGA could also issue you an infringement notice as an alternative to these actions.

In conjunction with pursuing civil or criminal sanctions, the TGA may also seek an injunction from a Federal Court to immediately cease your advertising.

The TGA can also alert the public to its concerns about particular therapeutic goods advertising through the use of public warning notices (section 42DY).

Please Note:

Subsection 42DV(6) states

As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

Relevant extracts from the Therapeutic Goods Act 1989

Therapeutic Goods Act 1989

Part 5-1 - Advertising and generic information

Division 6 - Directions about advertisements or generic information

42DV Directions about advertisements or generic information

Advertisements

1. If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:
   1. cease the advertisement;
   2. make a retraction;
   3. make a correction;
   4. recover any advertisement that is still in circulation;
   5. destroy the advertisement;
   6. cease making a particular claim or representation made by the advertisement.

Generic information

2. If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:
   1. withdraw the generic information;
   2. make a retraction;
   3. make a correction;
   4. recover any generic information that is still in circulation;
   5. destroy the generic information;
   6. cease making a particular claim or representation made by the generic information.

Conditions

3. A direction under subsection (1) or (2) may be subject to conditions specified in the direction.
4. Without limiting subsection (3), the conditions may relate to one or more of the following:
   1. the period for doing a thing the subject of the direction;
   2. in relation to the making of a retraction or correction, either or both of the following:
      1. the form and manner of the retraction or correction;
      2. the period for which the retraction or correction must be made publicly available;
   3. the reporting to the Secretary of compliance with the direction.

Direction not a legislative instrument

5. A direction under subsection (1) or (2) is not a legislative instrument.

Publication

6. As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

42DW Offences - contravening direction under section 42DV

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

Penalty: 100 penalty units.

1. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2) in relation to therapeutic goods; and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction; and
   4. either:
      1. the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
      2. the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and
   5. the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.
2. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction.
3. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction.
4. An offence against subsection (3) is an offence of strict liability.

42DX Civil penalty for contravening direction under section 42DV

A person contravenes this section if:

1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
2. the person does an act or omits to do an act; and
3. the act or omission contravenes the direction or a condition of the direction.

Maximum civil penalty:

1. for an individual - 5,000 penalty units; and
2. for a body corporate - 50,000 penalty units.

Request for reconsideration of an initial dections

This decision is a reviewable initial decision under section 60 of the TG Act. Under section 60, a person whose interests are affected by a 'reviewable' initial decision, can seek reconsideration of the initial decision.

As this document constitutes written notice of the making of an initial decision being given by the Secretary, a request for reconsideration of this initial decision must be given to the Minister within 90 days and be accompanied by any information that you wish to have considered.; A request for reconsideration given to the Minister outside the statutory 90 day reconsideration period cannot be accepted.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation.

Under section 60(3A) of the TG Act, the Minister (or the Minister's delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision unless the information is provided in response to a request from the Minister (or the Minister's delegate), or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable.

Guidelines for requesting reconsideration of an initial decision

A request for reconsideration should be made in writing, signed and dated by the person requesting reconsideration, should be titled "<insert person/company name> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989" and should include the following:

• a copy of the initial decision notification letter (or other evidence of notification);
• identify, and describe with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested;
• any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested; and
• an email address nominated for the purposes of receiving correspondence in relation to the request for reconsideration.

All requests for reconsideration should be given to the Minister by email:

Email: 'minister.hunt.DLO@health.gov.au' and copied to 'decision.review@health.gov.au'

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

If upon reconsideration by the Minister (or the Minister's delegate), you are dissatisfied with that decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision (see the Administrative Appeals Tribunal Act 1975 (AAT Act)).

NOTE: This initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister's delegate) as a result of a request for reconsideration under section 60 of the TG Act OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.

• anoxic brain injuries;
• stroke; and
• COVID-19.